Giant NIH research project finds some reluctance to share EHRs

The National Institutes of Health’s effort to amass an enormous database of information for powerful health studies has stumbled into an early snag: About one-fifth of those who have signed up for the precision medicine project balk when it comes to releasing their medical records to science.

The ambitious project, previously called the Precision Medicine Initiative and now known as All of Us, aims to get at least 1 million people to donate blood and bodily fluids, medical records, Fitbit data and other information that scientists will combine to make discoveries about staying healthy and treating disease.

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As of early October, about 4,000 people at 57 locations around the country had joined a pilot phase of the 10-year-plus program. A total of 14 health systems with 137 medical centers will eventually be part of the network, and volunteers can also sign up at places like blood banks and pharmacies. Walgreens will join the pilot in November, bringing in volunteers at its Phoenix and Sacramento stores.

In the pilot recruitments, though, after agreeing to participate in the study, an average of 20 percent volunteers failed to sign off on a separate release that enables access to their electronic health records, said NIH spokeswoman Alyssa Cotler. Researchers involved in the project — some of whom had estimated the figure at 30 percent — cited obstacles ranging from concern about privacy to a cumbersome hourlong online consent process.

Without the records, scientists won’t be able to correlate things like genetic mutations, environmentalpollutants and exercise patterns with the subjects’ health outcomes. Without that data, the power to predict which genes, pollutants, foods or activities affect health would be lost.

Josh Denny, a Vanderbilt University data scientist who co-chairs the All of Us steering committee, suspects participants may be getting lost in the lengthy sign-up. The initiative had to create 13 different EHR consent forms because of varying state laws. It also had to separate out the EHR consent from the primary consent request.

But some of the failed sign-ups surely point to privacy worries, said David Goldstein, director of the Institute for Genomic Medicine at Columbia University Medical Center. He oversees data collection at four New York hospitals, including two in Harlem, that the NIH expects to enroll a total of at least 150,000 volunteers.

“Some people are concerned about granting comprehensive access to their EHRs,” Goldstein said. “It’s going to be really important for us to be clear about why we want it — to clarify that there are important, exciting new things to be done by being able to comprehensively compare [DNA and other biological] data with EHR data.”

NIH’s approach in writing the consent forms was to be brutally frank. The form states plainly that researchers want access to sensitive health and medical treatment — for many years. And although NIH is building an ultra-secure system for banking information, there’s no 100 percent assurance that nothing will ever leak out.

“We want your eyes to be open,” said Eric Dishman, director of All of Us. “We want people to consent for a lifetime, or at least decades.”

But all those warnings and caveats left out the message about why this research is so vital — the “rah rah,” as one person involved in the project put it — and how key the EHR data is.

“We’re working to improve the messaging,” Goldstein said. “It wasn’t clear to everyone at beginning that if you didn’t grant access to EHR, you wouldn’t be a full participant.”

When you come down to it, it’s quite remarkable that — at a time when privacy violations-ranging from cyber hacks to NSA spying to Russian leaks and Google data mongering saturate the news — scientists think they can enroll a massive cross-section of the country in an open-ended, ambitious project that pries into their most intimate information (while promising to keep it private, of course).

And yet, about 800 scientists and other staff, marshaled by NIH around the country, are asking people to do just that.

“We are asking people from all over the United States to join All of Us so that our research reflects the diversity of our country,” says a leaflet that Goldstein’s team is handing out at hospitals and clinics in New York. The leaflet shows three men — one of whom appears Asian while the other two may be African-American or Latino — smiling down on a white girl in a wheelchair.

“People who join will give us information about their health, habits, and what it’s like where they live,” it says. “By looking for patterns, researchers may learn more about what affects people’s health.”

The background noise in society, with news of hacks and privacy leaks, adds to anxiety around sharing data, Goldstein said. “I can’t see how the Equifax thing helps us in any way in this challenge.”

And yet the health records are of primordial importance. Dishman, a former Intel executive and survivor of a rare kidney cancer, understands this like few others.

He was diagnosed in 1989, but it wasn’t until his genome was sequenced, in 2011, that his cancer was effectively treated. In the meantime he had to hire a company to chase down 20 years of medical records from 16 states.

For scientists and administrators working on All of Us, including NIH Director Francis Collins, who dreamed up the project, the stakes are high. In 2014, Collins pulled the plug on another massive study, the National Children’s Study, which sought to follow 100,000 children from the womb to adulthood, to turn up new genetic and environmental contributors to disease. The government had spent more than $1 billion on it over 14 years.

Congressional funding for All of Us is set for now — it got $300 million this fiscal year — and an HHS spokesman said the project “is a priority” for the department, directing a journalist to NIH and FDA websites on the program.

Both sides of the aisle in Congress support All of Us. But its philosophy was set during the Obama administration and it’s still closely associated with it. The core principles include inclusiveness and equity among races and socioeconomic status — recruiting a representative balance of races as well as rich and poor, urban and rural, old and young.

After the idea was proposed in 2015, President Barack Obama and Vice President Joe Biden talked up All of Us frequently in public forums. President Donald Trump hasn’t mentioned the initiative since he took office. HHS Secretary Tom Price was mum on it before he resigned Sept. 30 in a scandal over his use of private charter flights.

Supporters say it’s crucial to make sure future U.S. biomedical investments are based on an understanding of the entire population’s biology. Most research in the United States has been conducted on predominantly white men, whose response to drugs and other treatments may not be the same as some minorities.

The program is contracting with advocacy groups around the country to make sure the population in the study base is representative of the country. On July 25, for instance, NIH announced agreements for four groups to promote All of Us among poor seniors, Hispanics, African-Americans and the gay and lesbian community.

Eventually the plan calls for 14 health systems to recruit at least 600,000 participants, while 400,000 other people volunteer on their own, getting blood draws at places like the local Walgreens and feeding their medical data into the project electronically via apps.

The project eventually could make thousands of locations around the country available for recruitment, Dishman said. “Suddenly all these people who’ve never participated in research--because they don’t know about it or not near academic medical center — it’s amazingly game changing to distribute research capacity out to where people are,” he said.

The legacy of unethical research such as the Tuskeegee Syphilis Study has led to speculation that All of Us would have trouble recruiting racial minorities. But Dara Richardson-Heron, who heads enrollment for the program, says she’s found less resistance than expected.

“When you talk about them not wanting to be involved in research, many say, ‘I’ve never been asked,’” she said. “There’s no one I’ve met who isn’t excited about what we can achieve.”